Bimekizumab 5-Year Data: Sustained Skin Clearance, Long-Term Efficacy in PsO

Dual inhibition with bimekizumab-bkzx (BIMZELX) demonstrated high efficacy and sustained clinical benefits across different adult patient populations living with moderate-to-severe plaque psoriasis, UCB said in announcing further long-term data from the Phase 3 trials and their open-label extensions.

“A primary treatment goal for people living with psoriasis is durable, high rates of complete skin clearance. These 5-year bimekizumab-bkzx results provide valuable evidence for clinical decision-making,” Andrew Blauvelt, MD, MBA, Chair, Medical Board, National Psoriasis Foundation, said in a press release. “The sustained complete skin clearance offers important insights into the potential of bimekizumab-bkzx’s dual inhibition to provide long-term management of this chronic inflammatory condition.”

Among patients with PSO only at baseline, who were at risk of progression to psoriatic arthritis (PsA), 68.7–71.6% achieved complete skin clearance (Psoriasis Area and Severity Index [PASI]100) at 3 years, generally consistent with the overall treated group, who achieved 72%. Similar results were seen in all patients with PSO, including those with PsA at baseline. Among the 153 US/Canadian patients who completed an open-label extension period to 5 years,* 67.7% achieved PASI100, while 84.9% achieved PASI90. In this subgroup over the 5-year period, BIMZELX was generally well tolerated with no unexpected safety findings.

“Psoriasis is a chronic condition that increases the risk of developing other serious health issues,” Fiona du Monceau, Executive Vice President, Head of Patient Evidence, UCB, said in the release. “These 5-year results highlight the robust potential of bimekizumab-bkzx in transforming patient outcomes by offering the possibility of lasting, complete skin clearance. Bimekizumab-bkzx is aiming to set a new standard for treatment success, and our belief in its innovative dual inhibition approach is reflected in our dedication to head-to-head trials, including the BE BOLD Phase 3 trial in psoriatic arthritis.”

UCB’s data for BIMZELX in moderate-to-severe PSO was being presented as six posters at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida.

*All patients received BIMZELX every four weeks (Q4W) to Week 16, then received either Q4W or Q8W depending upon response to treatment. Receiving Q4W to Week 16, then Q8W thereafter is the approved dosing regimen (Q4W/Q8W). Results included patients receiving both Q4W/Q8W and Q4W/Q4W.